Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Vehicle:
other: absolute ethanol
Concentration / amount:
Test article in a 0.1% (w/w) suspension in absolute ethanol.

Concentration of test material and vehicle used for each challenge:
Test article in a 50% (w/w) paste in absolute ethanol
Challengeopen allclose all
Route:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Vehicle:
other: absolute ethanol
Concentration / amount:
Test article in a 0.1% (w/w) suspension in absolute ethanol.

Concentration of test material and vehicle used for each challenge:
Test article in a 50% (w/w) paste in absolute ethanol
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Challenge controls:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive control substance(s):
not specified
Remarks:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Study design: in vivo (LLNA)

Positive control substance(s):
not specified
Statistics:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

Positive control results:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary study.

Signs of irritation during induction: yes

Evidence of sensitisation of each challenge concentration: no

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test article has been determined not to be a dermal sensitiser.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.

Sensitisation was assessed by using OECD Guideline 406 (1981) EEC Directive 84/449 (1984) - Annex V - Method B6

T-1540N was demonstrated not to be a sensitiser.